Concern for countries left out of Gilead HIV patent pool

The news that Gilead Sciences has signed up to the Medicines Patent Pool to improve access to HIV treatments in poor countries has been generally welcomed by aid agencies and charities, but they warn that countries excluded from the deal may have to go down the compulsory licensing path.

The agreement with Gilead, the first drugmaker to join forces with the MPP, allows for the production of generic copies of Viread (tenofovir), Emtriva (emtricitabine) and two pipeline treatments - cobicistat and elvitegravir. It also covers Quad, an investigational combination of the four aforementioned drugs in a single pill for HIV. The licenses will allow for the supply of tenofovir and emtricitabine in 111 countries, for cobicistat in 102 countries, and for elvitegravir and Quad in 99 countries.

Medicins Sans Frontieres (MSF – Doctors Without Borders) says there are many positive elements to the news, noting that the licence is the first of its kind to "explicitly incorporate the potential use of public health safeguards". It allows medicines to be exported to countries excluded from the agreement when their governments choose to override the patent with a compulsory licence, and also allows producers to exit the agreement for any one of the drugs if Gilead loses a patent because of a legal challenge. The agreement "has also been made public, which sets an important precedent for transparency", MSF adds.

Move falls 'significantly short'

However, the medical charity claims that it falls "significantly short of what is needed to fully meet the public health needs for HIV/AIDS". MSF argues that it limits "price-busting competition by confining manufacturing to one country (India) and includes narrow supply options for active pharmaceutical ingredients needed to make the drugs".

Most critically, MSF says, people living with HIV in certain middle-income countries are excluded, which "contrasts sharply to the first pool licence granted by the US National Institutes of Health for all developing countries". It states that countries that are left out "will need to aggressively pursue non-voluntary paths like compulsory licences". Manufacturers in Thailand and Brazil, which have capacity to produce, have been left out.

Michelle Childs, at MSF’s Campaign for Access to Essential Medicines, noted that the agreement is "an improvement over what other big pharma companies are doing to ensure access to their patented AIDS medicines in developing countries”. However, she added that “some caution is needed because in several key areas, Gilead is not going beyond the status quo" and "this licence should not become the template for future agreements".

Ms Childs went on to say that drugmakers currently negotiating with the MPP "should agree to licenses that more fully meet public health needs". She concluded by stating that “we expect all companies, including Johnson and Johnson, Abbott and Merck & Co to also put their patents in the Pool, just as we hope that countries that don’t benefit from this agreement will use all means including compulsory licenses to increase access to HIV medicines for their people".

Generous gesture

Michael Weinstein, president of the AIDS Healthcare Foundation (AHF) in the USA. commended Gilead for "a generous gesture that will do doubt ensure and improve access to newer AIDS treatments in many developing countries".

He urged other drug companies to follow Gilead’s lead and share their patents with the pool. However, echoing MSFs stance, Mr Weinstein notes that the agreement "specifically excludes middle-income countries such as Mexico, which has been hard-hit by the epidemic and could benefit from improved access to these drugs via the pool".

He ended by saying that AHF is now asking Gilead to "reduce prices directly for such AIDS drugs in hard-hit middle-income countries".